Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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8-500
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Standard | |
ISO 5832-12 Third edition 2019-02 Implants for surgery - Metallic materials - Part 12: Wrought cobalt-chromium-molybdenum alloy |
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Scope/AbstractThis document specifies the requirements for two wrought cobalt 28-chromium 6-molybdenum alloys used for surgical implants. The properties apply specifically to wrought bar, rod and wire.
NOTE 1 The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this document.
NOTE 2 The high carbon content of this alloy produces a structure containing a significant carbide distribution. This can be adjusted either in the production of the bar or in subsequent thermomechanical processing to produce the final device. Carbide distribution in the final device is not included as part of this document. |
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Extent of Recognition
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Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. |
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Transition Period
FDA recognition of ISO 5832-12 Second edition 2007-05-01 [Rec# 8-351] will be superseded by recognition of ISO 5832-12 Third edition 2019-02 [Rec# 8-500]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-351] until July 24, 2022. After this transition period, declarations of conformity to [Rec# 8-351] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§872.3950 |
Glenoid Fossa Prosthesis |
Class 3 |
MPI |
§872.3960 |
Mandibular Condyle Prosthesis |
Class 3 |
MPL |
§872.4600 |
Lock, Wire, And Ligature, Intraoral |
Class 2 |
DYX |
§872.3645 |
Implant, Subperiosteal |
Class 2 |
ELE |
§872.3940 |
Joint, Temporomandibular, Implant |
Class 3 |
LZD |
§872.4760 |
External Mandibular Fixator And/Or Distractor |
Class 2 |
MQN |
§872.4760 |
Implant, Transmandibular |
Class 2 |
MDL |
§872.4760 |
Plate, Bone |
Class 2 |
JEY |
§872.4880 |
Screw, Fixation, Intraosseous |
Class 2 |
DZL |
21 CFR 888.3XXX Metallic components of all implantables |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |